Pharmacokinetics, Safety and Tolerability of Oral Semaglutide in Subjects with Renal Impairment.

Granhall C, Søndergaard FL, Thomsen M, Anderson TW

Clinical pharmacokinetics1 Dec 2018Cited by 88 (Europe PMC)

PMID29623579PMCIDPMC6267549DOI10.1007/s40262-018-0649-2PepBankPUB-29623579

Read at source PubMedAsk about this study

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: CC BY-NC. Results still quote short attributed sentences.

Results from this study6

6 results from studies that gave the peptide. 6 results from people.

01HumanNon-randomized trialPharmacokinetics
Oral semaglutide AUC after the tenth dose did not vary in a consistent pattern across renal function groups.
In plain wordsKidney function did not change in a consistent way how much oral semaglutide was in the blood.
Peptide
Semaglutide
Outcome
No significant changeSemaglutide AUC after the tenth dose by renal function
Study
n = 71
Comparator
Normal renal function
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
5 mg for 5 days followed by 10 mg for 5 days · oral · 10 daysAs given in this study (human).
Source sentences
Summary
Semaglutide exposure (area under the plasma concentration-time curve from time zero to 24 h after the tenth dose and maximum concentration after the tenth dose) did not vary in a consistent pattern across the renal function groups.
1 context sentence(design, population, supporting numbers)
Summary · context
Subjects were categorised as having normal renal function (n = 24), mild (n = 12), moderate (n = 12) or severe (n = 12) renal impairment, or end-stage renal disease (ESRD) requiring haemodialysis (n = 11) and received once-daily oral semaglutide (5 mg for 5 days followed by 10 mg for 5 days) in the…
Report a problemFND-2962357901
02HumanNon-randomized trialPharmacokinetics
Oral semaglutide maximum concentration after the tenth dose did not vary in a consistent pattern across renal function groups.
In plain wordsKidney function did not change in a consistent way the peak level of oral semaglutide in the blood.
Peptide
Semaglutide
Outcome
No significant changeSemaglutide Cmax after the tenth dose by renal function
Study
n = 71
Comparator
Normal renal function
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
5 mg for 5 days followed by 10 mg for 5 days · oral · 10 daysAs given in this study (human).
Source sentences
Summary
Semaglutide exposure (area under the plasma concentration-time curve from time zero to 24 h after the tenth dose and maximum concentration after the tenth dose) did not vary in a consistent pattern across the renal function groups.
1 context sentence(design, population, supporting numbers)
Summary · context
Subjects were categorised as having normal renal function (n = 24), mild (n = 12), moderate (n = 12) or severe (n = 12) renal impairment, or end-stage renal disease (ESRD) requiring haemodialysis (n = 11) and received once-daily oral semaglutide (5 mg for 5 days followed by 10 mg for 5 days) in the…
Report a problemFND-2962357902
03HumanNon-randomized trialPharmacokinetics
Renal impairment had no apparent effect on the half-life of oral semaglutide.
In plain wordsKidney impairment had no apparent effect on how long oral semaglutide stayed in the body.
Peptide
Semaglutide
Outcome
No significant changeSemaglutide half-life by renal function
Study
n = 71
Comparator
Normal renal function
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
5 mg for 5 days followed by 10 mg for 5 days · oral · 10 daysAs given in this study (human).
Measurements
Half-life
152 to 165 h
geometric mean range across groups
Source sentences
Summary
Similarly, there was no apparent effect of renal impairment on the semaglutide half-life (geometric mean range 152-165 h).
1 context sentence(design, population, supporting numbers)
Summary · context
Subjects were categorised as having normal renal function (n = 24), mild (n = 12), moderate (n = 12) or severe (n = 12) renal impairment, or end-stage renal disease (ESRD) requiring haemodialysis (n = 11) and received once-daily oral semaglutide (5 mg for 5 days followed by 10 mg for 5 days) in the…
Report a problemFND-2962357903
04HumanNon-randomized trialPharmacokinetics
Semaglutide was not detected in urine, except in one subject in the end-stage renal disease group.
In plain wordsSemaglutide was not found in urine, except in one person with end-stage kidney disease.
Peptide
Semaglutide
Outcome
Not applicableUrinary excretion of semaglutide
Study
n = 71
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
5 mg for 5 days followed by 10 mg for 5 days · oral · 10 daysAs given in this study (human).
Source sentences
Summary
Except for one subject in the ESRD group, semaglutide was not detected in urine.
1 context sentence(design, population, supporting numbers)
Summary · context
Subjects were categorised as having normal renal function (n = 24), mild (n = 12), moderate (n = 12) or severe (n = 12) renal impairment, or end-stage renal disease (ESRD) requiring haemodialysis (n = 11) and received once-daily oral semaglutide (5 mg for 5 days followed by 10 mg for 5 days) in the…
Report a problemFND-2962357904
05HumanNon-randomized trialPharmacokinetics
Haemodialysis did not affect the pharmacokinetics of oral semaglutide.
In plain wordsDialysis did not change how the body handled oral semaglutide.
Peptide
Semaglutide
Outcome
No significant changeEffect of haemodialysis on semaglutide pharmacokinetics
Study
n = 71
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
5 mg for 5 days followed by 10 mg for 5 days · oral · 10 daysAs given in this study (human).
Source sentences
Summary
Haemodialysis did not affect the pharmacokinetics of semaglutide.
1 context sentence(design, population, supporting numbers)
Summary · context
Subjects were categorised as having normal renal function (n = 24), mild (n = 12), moderate (n = 12) or severe (n = 12) renal impairment, or end-stage renal disease (ESRD) requiring haemodialysis (n = 11) and received once-daily oral semaglutide (5 mg for 5 days followed by 10 mg for 5 days) in the…
Report a problemFND-2962357905
06HumanNon-randomized trialSafety outcome
Adverse events with oral semaglutide in people with and without renal impairment matched those seen with other GLP-1 receptor agonists, and no safety concerns were identified.
In plain wordsSide effects matched those of similar drugs, and no safety concerns were found, in people with and without kidney impairment.
Peptide
Semaglutide
Outcome
Not applicableAdverse events with oral semaglutide in renal impairment
Study
n = 71
Outcome group
Adverse events · Whole body
Studied dose
5 mg for 5 days followed by 10 mg for 5 days · oral · 10 daysAs given in this study (human).
Source sentences
Summary
Adverse events were in line with those observed for other GLP-1 receptor agonists and no safety concerns were identified.
1 context sentence(design, population, supporting numbers)
Summary · context
Subjects were categorised as having normal renal function (n = 24), mild (n = 12), moderate (n = 12) or severe (n = 12) renal impairment, or end-stage renal disease (ESRD) requiring haemodialysis (n = 11) and received once-daily oral semaglutide (5 mg for 5 days followed by 10 mg for 5 days) in the…
Report a problemFND-2962357906

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 1NCT02014259

Pharmacokinetics, Safety and Tolerability of Oral Semaglutide in Subjects With Various Degrees of Impaired Renal Function

Novo Nordisk A/Sn = 7111 Dec 2013 to 24 Oct 2014

Diabetes · Diabetes Mellitus, Type 2 · Healthy

Trial page ClinicalTrials.govUpdated 19 Apr 2018

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
11 Oct 2026, 00:50 UTC
Study results updated
Version 1
9 Oct 2026, 03:06 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

PepBank is a research reference. Talk to a doctor before you use any peptide.